Novartis Wins Egyptian Drug Authority Approval for Kisqali as Adjuvant Therapy in Early Breast Cancer
核心洞察
Novartis received Egyptian Drug Authority (搜索) approval for Kisqali as adjuvant treatment of HR-positive, HER2-negative stage II and III early breast cancer (搜索) at high risk of recurrence.
The cyclin-dependent kinase inhibitor is indicated in combination with an aromatase (搜索) inhibitor for adult patients, expanding use earlier in the treatment journey.
Breast cancer (搜索) accounts for roughly 37% of all female cancer cases in Egypt, with one of the highest incidence rates in the WHO Eastern Mediterranean Region.
Novartis has received approval from the Egyptian Drug Authority (搜索) (EDA) for a new indication for Kisqali as an adjuvant treatment in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative stage II and III early breast cancer (搜索) at high risk of recurrence. The cyclin-dependent kinase inhibitor (CDKi) is indicated for use in combination with an aromatase (搜索) inhibitor, according to the company's announcement.
The approval marks a significant advancement in Egypt's national fight against breast cancer (搜索), which accounts for approximately 37% of all female cancer cases in the country and is a leading cause of cancer mortality among Egyptian women, according to WHO Globocan 2024 data cited in the release. HR+/HER2− is the most common breast cancer subtype globally.
"This approval reflects our commitment to reimagining cancer care in Egypt by bringing innovation earlier in the treatment journey, while continuing to work alongside clinicians, health authorities and patient communities to improve outcomes for eligible patients," said Jihane El Murr, Country President of Novartis Egypt.
A Distinctive Epidemiology in Egypt
Egypt presents a disease profile that differs from many Western markets. According to 2022 reports, the country has one of the highest incidence rates in the World Health Organization Eastern Mediterranean Region, at 55.4 cases per 100,000 women. Studies indicate that 57% of Egyptian breast cancer (搜索) patients are premenopausal, with a mean age at diagnosis of 50.5 years — a pattern of younger onset that the company highlighted as a unique challenge.
The approval covers patients with stage II and III disease at high risk of recurrence, positioning the CDK inhibitor in the adjuvant setting rather than the metastatic setting.
Access, Education and Health System Partnerships
Novartis said it is coordinating with relevant authorities to facilitate access for eligible patients through regulatory and healthcare system channels, while supporting medical professionals with educational initiatives designed to optimize treatment adherence and outcomes. The company noted that healthcare professionals should consult the locally approved prescribing information when making treatment decisions.
The approval aligns with Egypt Vision 2030 priorities and broader national efforts to strengthen oncology care. These efforts complement the government's Presidential Initiative for Women's Health, which has provided screening and awareness services to more than 70 million women since its launch in 2019, detecting and registering more than 35,390 breast cancer (搜索) cases.
Under a Memorandum of Understanding signed with the Egyptian Healthcare Authority in 2025, Novartis Egypt agreed to enhance physicians' capabilities, strengthen early diagnosis and treatment mechanisms in line with international healthcare standards, and develop an online platform to help doctors coordinate breast cancer (搜索) treatment plans. Novartis also sponsored the "Hekaya Wardy" awareness campaign, which promotes early detection and addresses cultural taboos surrounding the disease.
Longstanding Oncology Presence
Novartis noted that it has been active in breast cancer (搜索) research and innovation for more than 35 years. Its Egyptian affiliate, described as a leading healthcare partner in the country for more than six decades, reaches 16 million patients across 47 brands and employs more than 600 associates, with a local manufacturing footprint of 1 billion units annually and exports to over 60 countries. The company states that its medicines reach more than 250 million people worldwide.